NCT04826523Completed
Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)
Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea. Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 31 Mar 2021
- Start date
- 5 Apr 2021
- Primary completion date
- 20 Oct 2025
- Lead sponsor
- AbbVie
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04826523
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 5 Apr 2021 to the primary completion date, 20 Oct 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants receiving Venetoclax in clinical trials.
Other
- Participants with contraindications to Venetoclax as listed on the approved local label.
Who the study is looking for
- --Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kosin University Gospel Hospital /ID# 257399 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital /ID# 239010 Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kyungpook National University Hospital /ID# 257398 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Yeungnam University Medical Center /ID# 239007 Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital /ID# 257478 Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Unknown status |
| Gachon University Gil Medical Center /ID# 239008 Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Yonsei University Health System Severance Hospital /ID# 239006 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 257477 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 239009 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Anam Hospital /ID# 231022 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.